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As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.
Job Responsibility:
Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed
Support authority/ethics response to requests as applicable
In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data
Coordinates and supports trial medical writer in providing the CTR
Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors
Support results/documents disclosure of global registries
Requirements:
Bachelor’s degree and minimum 6 years of relevant global trial management experience
Experience in early phase Oncology or Immunology is essential
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
Effective communication skills via verbal, written and presentation abilities
What we offer:
Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests